[Anke Fronius]

I am a bit late to this discussion, but I frequently find myself in a situation where I would like to file a master/template, but cannot find a corresponding artifact on trial level.

[Anke Fronius]

So far I have filed everything under submissions, but I think if it is only a notification (i.e., you won’t get an approval letter) relevant correspondence would also make sense. Sorry – not helpful I’m afraid 😀

[Anke Fronius]

Hi, I have no experience in qualifying Sharepoint as an eTMF but have experienced a company using Sharepoint to file TMF content without ensuring the system meets all requirements, such as audit trail. Besides from this obvious short fall, other struggles were lack of metadata capture, not being able to stack documents and most annoyingly not being able to file documents in the correct aftifact because the overall file path was too long.

[Anke Fronius]

Hi, not sure, but I would probably use 04.04.01.

[Anke Fronius]

Thanks Angela. Neither have I. I was surprised this seems to be a requirement.

[Anke Fronius]

Hi Eldin,
Thanks for your reply. GCP does not seem to refer to an (internal) approval, but specifically to an investigator signature to confirm they agree to the template CRF.

GCP mentiones protocol and CRF signature page in the same sentence (“SIGNED PROTOCOL AND AMENDMENTS, IF ANY, AND SAMPLE CASE REPORT FORM (CRF)”. To document investigator and sponsor agreement to the protocol/amendment(s) and CRF.. However, the set-up in the reference model is different for them:
– For the protocol, there are artifacts for the signature pages
– For the CRF, there is no artifact for the signature page.

When 2 documents are mentioned with the same requirements in the same sentence, I would be expecting they are treated the same in the reference model, too.

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